Diabetes Mellitus, Type 2Phase 2NCT00631488
A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)
A Phase 2 study testing MK-0893, Sitagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by Merck Sharp & Dohme LLC.
Trial summary
This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- MK-0893, Sitagliptin and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy
Who cannot join
- Participants have a history of Type 1 Diabetes Mellitus
- Participants taking insulin or thiazolidinediones (TZDs: peroxisome proliferator-activated receptor [PPAR]-gamma agonists)
- Participants who have a contraindication to metformin or sitagliptin
About this study
Official title: A Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of MK0893 in Combination With Sitagliptin or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- MK-0893, Sitagliptin, Metformin, Placebo for MK-0893, Placebo for Sitagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-0893Drug
Initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks).
SitagliptinDrug
Also called JANUVIA™, MK0431
Sitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).
MetforminDrug
Also called GLUCOPHAGE®
Metformin taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin then administered throughout the double-blind treatment period (4 weeks).
Placebo for MK-0893Drug
Matching placebo for MK-0893 was orally administered for the loading dose (200 mg) and for the following daily treatment (40 mg) over the 4 week double blind treatment period.
Placebo for SitagliptinDrug
Matching placebo for Sitagliptin (100 mg) administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).
Placebo for MetforminDrug
Metformin-matched placebo taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin-matched placebo then administered throughout the double-blind treatment period (4 weeks).
| Study group | Role | What they receive |
|---|---|---|
| MK-0893 + Sitagliptin | Experimental | Not described Receives: Drug: MK-0893; Drug: Sitagliptin; Drug: Placebo for Metformin |
| MK-0893 + Metformin | Experimental | Not described Receives: Drug: MK-0893; Drug: Metformin; Drug: Placebo for Sitagliptin |
| Sitagliptin + Metformin | Active comparator | Not described Receives: Drug: Sitagliptin; Drug: Metformin; Drug: Placebo for MK-0893 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels
Measured: BL, 4 weeks (end of double-blind treatment period)
Secondary outcomes (4)
Change From BL to Week 4 in Fasting Plasma Glucose (FPG)
Measured: BL, 4 weeks (end of double-blind treatment period)
Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)
Measured: BL, 4 weeks (end of double-blind treatment period)
Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC
Glucagon-Like Peptide-1 (GLP-1) is an incretin hormone that acts as a potent insulin secretegogue in response to nutrient ingestion and stimulates glucose disposition. The total AUC of Total GLP-1 levels was calculated from blood sample data measured after the morning meal.
Measured: BL, 4 weeks (end of double-blind treatment period)
Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC
GLP-1 is cleaved from proglucagon to form the active peptide GLP-1. The active form promotes suppression of glucagon secretion. The total AUC of Active GLP-1 levels was calculated from blood sample data measured after the morning meal.
Measured: BL, 4 weeks (end of double-blind treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631488
- Sponsor's protocol ID
- 0893-015
- Other IDs
- 2007_646
- Status last verified
- Dec 2016
- First submitted
- 21 Feb 2008
- Last updated
- 2 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of MK0893 in Combination With Sitagliptin or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
- ClinicalTrials.gov ID
- NCT00631488
- Acronym / sponsor ID
- 0893-015
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 7 Mar 2008 (estimated)
- Results
- Posted 17 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MK-0893 + Sitagliptin | Experimental | Drug: MK-0893, Drug: Sitagliptin, Drug: Placebo for Metformin |
| MK-0893 + Metformin | Experimental | Drug: MK-0893, Drug: Metformin, Drug: Placebo for Sitagliptin |
| Sitagliptin + Metformin | Active comparator | Drug: Sitagliptin, Drug: Metformin, Drug: Placebo for MK-0893 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy
Key exclusion criteria (3 listed)
- Participants have a history of Type 1 Diabetes Mellitus
- Participants taking insulin or thiazolidinediones (TZDs: peroxisome proliferator-activated receptor [PPAR]-gamma agonists)
- Participants who have a contraindication to metformin or sitagliptin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-0893Initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks). | Drug | MK-0893 + Metformin, MK-0893 + Sitagliptin |
| SitagliptinAlso: JANUVIA™, MK0431Sitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks). | Drug | MK-0893 + Sitagliptin, Sitagliptin + Metformin |
| MetforminAlso: GLUCOPHAGE®Metformin taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin then administered throughout the double-blind treatment period (4 weeks). | Drug | MK-0893 + Metformin, Sitagliptin + Metformin |
| Placebo for MK-0893Matching placebo for MK-0893 was orally administered for the loading dose (200 mg) and for the following daily treatment (40 mg) over the 4 week double blind treatment period. | Drug | Sitagliptin + Metformin |
| Placebo for SitagliptinMatching placebo for Sitagliptin (100 mg) administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks). | Drug | MK-0893 + Metformin |
| Placebo for MetforminMetformin-matched placebo taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin-matched placebo then administered throughout the double-blind treatment period (4 weeks). | Drug | MK-0893 + Sitagliptin |
Primary outcome
Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels
Time frame: BL, 4 weeks (end of double-blind treatment period)
4 secondary outcomes
Change From BL to Week 4 in Fasting Plasma Glucose (FPG)
Time frame: BL, 4 weeks (end of double-blind treatment period)
Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)
Time frame: BL, 4 weeks (end of double-blind treatment period)
Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC
Time frame: BL, 4 weeks (end of double-blind treatment period)
Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC
Time frame: BL, 4 weeks (end of double-blind treatment period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK-0893, Sitagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels (time frame: BL, 4 weeks (end of double-blind treatment period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2017.